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FDA 510(k)

CO2 PNEUMO-DISSECTOR

K-Number: K972647 · 1998-04-10

ApplicantCook Urological, Inc.
Decision Date1998-04-10
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CO2 PNEUMO-DISSECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 1998-04-10 under 510(k) number K972647. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CO2 PNEUMO-DISSECTOR?

CO2 PNEUMO-DISSECTOR is a medical device that received FDA 510(k) clearance on 1998-04-10. The listed applicant is Cook Urological, Inc.. The 510(k) number is K972647.

When did CO2 PNEUMO-DISSECTOR receive FDA 510(k) clearance?

CO2 PNEUMO-DISSECTOR received FDA 510(k) clearance on 1998-04-10, under 510(k) number K972647.

Who is the listed applicant for CO2 PNEUMO-DISSECTOR?

The FDA 510(k) record lists Cook Urological, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2 PNEUMO-DISSECTOR?

The FDA product code for CO2 PNEUMO-DISSECTOR is HET.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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